Exhibit 99.1
Aytu BioScience Reports Third Quarter Fiscal 2020 Financial Results
 
Company Reports Revenue for the Three Months Ended March 31, 2020 of $8.2M, Up 243% Year-over-Year
 
$62.5 Million in Cash and Cash Equivalents as of March 31, 2020
 
Management to Host Conference Call at 4:30 PM ET
 
ENGLEWOOD, CO / ACCESSWIRE / May 14, 2020 / Aytu BioScience, Inc. (NASDAQ:AYTU), a specialty pharmaceutical company (the “Company”) focused on commercializing novel products that address significant medical needs, today reported financial results for the three months ended March 31, 2020 and provided a corporate update.
 
Third Quarter Fiscal 2020 and Other Recent Corporate Developments:
 
COVID-19 Update
 
The Company secured an exclusive U.S. distribution agreement for a COVID-19 IgG/IgM rapid test from Hong Kong-based L.B. Resources.
 
The Company announced a second distribution agreement for a COVID-19 IgG/IgM rapid test with Singapore-based Biolidics Limited.
 
The Company received an initial shipment of 100,000 COVID-19 IgG/IgM rapid tests and began shipping to U.S. customers.
 
The Company announced positive results from an independently conducted clinical study of the Zhejiang Orient Gene Biotech COVID-19 IgG/IgM rapid test demonstrating test accuracy of 98.0% and 94.1% for IgG and IgM, respectively, when using PCR-positive cases as true positives.
 
The Company signed an exclusive worldwide license from Cedars-Sinai to develop and commercialize the Healight Platform Technology ("Healight"). This ultraviolet light-based medical device technology platform, developed by scientists at Cedars-Sinai, is being studied as a potential treatment for coronavirus and other severe respiratory infections.
 
The Company signed an agreement with Sterling Medical Devices to finalize the development of Healight.
 
Rx Business Update
 
The Company announced the acceptance and publication of the Natesto® Spermatogenesis Study results in the Journal of Urology. The study concluded that Natesto was effective in returning hypogonadal men to back to normal testosterone levels, significantly improve erectile function and quality of life, preserve gonadotropin hormones, and most importantly preserve semen parameters through 6 months of treatment.
 
Consumer Health Business Update
 
The Company completed the acquisition of Innovus Pharmaceuticals to expand the Company’s portfolio to include an approximately $25 million annual consumer health portfolio.
 
Company’s newly acquired Innovus consumer health subsidiary launched its first post-acquisition product Regoxidine®, an over-the-counter foam formulation of minoxidil for hair regrowth available for use by both men and women, targeting over 11 Million U.S. consumers who purchased hair regrowth products in 2019.
 
Financial Results and Financing Update
 
Revenue: The Company recorded revenue of $8.2 million for the three months ended March 31, 2020, an increase of approximately 243% compared to the three months ended March 31, 2019, and an increase of approximately 157% compared to the three months ended December 31, 2019.
 
The Company’s third quarter revenue results represent partial revenue contribution from the acquisition of Innovus Pharmaceuticals, which closed on February 14, 2020, and zero revenue contribution from COVID-19 IgG/IgM rapid tests first received at the start of the fiscal fourth quarter on April 1, 2020.
 
 
 
 
Cash and cash equivalents: As of March 31, 2020, the Company had cash, cash equivalents and restricted cash of $62.5 million, compared to $5.5 million as of December 31, 2019.
 
Shares Outstanding: At March 31, 2020, the Company had 100,610,380 shares of common stock outstanding. There are currently no outstanding preferred shares.
 
Financings: The Company completed three registered direct offerings priced at-the-market and announced the exercise of 17.1 million warrants.
 
Commenting on the third quarter of fiscal 2020, Josh Disbrow, Chief Executive Officer of Aytu BioScience, stated, “We had a transformative third quarter and have had exceptional performance in the period year to date. Starting with revenue, in Q3 we reported our highest ever revenue quarter with $8.2 million in top line, up 243% year over year. Additionally, through our recent equity offerings and warrant exercises we strengthened our balance sheet and have $62.5 million in cash, restricted cash, and cash equivalents as of March 31st. Further, by signing two distribution agreements for COVID-19 rapid tests and securing an exclusive worldwide licensing agreement with Cedars-Sinai for the Healight technology platform, the Company is well positioned to continue to take the fight to COVID-19. With a large number of tests having just arrived at our warehouse this week, we can now help even more providers screen patients for COVID-19 IgG and IgM antibodies as we collectively work to reopen the country.”
 
Mr. Disbrow continued, “Looking at our growth drivers beyond fiscal Q3, the Company has three strategic areas from which we expect to make progress going forward: growth of our organic Rx and consumer health business segments, continuing the distribution of the two COVID-19 antibody test kits for which we’ve secured distribution rights, and progressing the development of the Healight platform technology as a prospective treatment for COVID-19 and other severe infections. Organically in Q4, we will have our first full quarter of revenue contribution from the newly acquired Innovus consumer health segment. Importantly, the consumer business has already launched Regoxidine, for hair regrowth, and more near-term consumer health product launches are planned. With respect to the prescription business, we reported recently published Phase IV data for Natesto and demonstrated that a testosterone replacement therapy can increase serum testosterone levels while maintaining sperm concentration, motility, and total motile sperm count. We believe this clinical development enables Natesto to stand apart from other testosterone replacement therapies in offering a treatment solution for hypogonadal men wishing to maintain fertility. In terms of COVID-19 testing revenue, we began shipping product in April, so we expect a significant increase in revenue in Q4 now that those test sales are under way. Additionally, we signed an exclusive global license with Cedars-Sinai for Healight, which represents a novel opportunity as a potential treatment for COVID-19 and other serious infections for hospitalized patients.”
 
Mr. Disbrow concluded, “When considering our organic growth, a $62.5 million cash balance, our expected revenue from the COVID-19 antibody test kits, the addition of the Healight opportunity, and a cleaned-up capital structure, I have never been more optimistic about the future of Aytu BioScience.”
 
Conference Call Information
 
The company will host a live conference call at 4:30 p.m. ET today. The conference call can be accessed by dialing either:
 
877-407-9124 (toll-free)
201-689-8584 (international)

The webcast will be accessible live and archived on Aytu BioScience's website, within the Investors section under Events & Presentations, at aytubio.com, for 90 days.
 
A replay of the call will be available for fourteen days. Access the replay by calling 1-877-481-4010 (toll-free) or 919-882-2331 (international) and using the replay access code 34718.
 
About Aytu BioScience, Inc.
 
Aytu BioScience, Inc. is a commercial-stage specialty pharmaceutical company focused on commercializing novel products that address significant patient needs. The Company currently markets a portfolio of prescription products addressing large primary care and pediatric markets. The primary care portfolio includes (i) Natesto®, the only FDA-approved nasal formulation of testosterone for men with hypogonadism (low testosterone, or "Low T"), (ii) ZolpiMist™, the only FDA-approved oral spray prescription sleep aid, and (iii) Tuzistra® XR, the only FDA-approved 12-hour codeine-based antitussive syrup. The pediatric portfolio includes (i) AcipHex® Sprinkle™, a granule formulation of rabeprazole sodium, a commonly prescribed proton pump inhibitor; (ii) Cefaclor, a second-generation cephalosporin antibiotic suspension; (iii) Karbinal® ER, an extended-release carbinoxamine (antihistamine) suspension indicated to treat numerous allergic conditions; and (iv) Poly-Vi-Flor® and Tri-Vi-Flor®, two complementary prescription fluoride-based supplement product lines containing combinations of fluoride and vitamins in various for infants and children with fluoride deficiency. Aytu recently acquired exclusive U.S. distribution rights to two COVID-19 IgG/IgM rapid tests. These coronavirus tests are solid phase immunochromatographic assays used in the rapid, qualitative and differential detection of IgG and IgM antibodies to the 2019 Novel Coronavirus in human whole blood, serum or plasma. The Company also recently signed an exclusive worldwide licensing agreement with Cedars-Sinai to develop the Healight™ technology platform, which is being studied as a potential treatment for COVID-19 and other severe respiratory infections.
 
Aytu recently acquired Innovus Pharmaceuticals, a specialty pharmaceutical company commercializing, licensing and developing safe and effective consumer healthcare products designed to improve men's and women's health and vitality. Innovus commercializes over thirty-five consumer health products competing in large healthcare categories including diabetes, men's health, sexual wellness and respiratory health. The Innovus product portfolio is commercialized through direct-to-consumer marketing channels utilizing the Company's proprietary Beyond Human® marketing and sales platform.
 
Aytu's strategy is to continue building its portfolio of revenue-generating products, leveraging its focused commercial team and expertise to build leading brands within large therapeutic markets. For more information visit aytubio.com and visit innovuspharma.com to learn about the Company's consumer healthcare products.
 
 
 
 
Forward-Looking Statement
 
This press release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, or the Exchange Act. All statements other than statements of historical facts contained in this presentation, are forward-looking statements. Forward-looking statements are generally written in the future tense and/or are preceded by words such as ''may,'' ''will,'' ''should,'' ''forecast,'' ''could,'' ''expect,'' ''suggest,'' ''believe,'' ''estimate,'' ''continue,'' ''anticipate,'' ''intend,'' ''plan,'' or similar words, or the negatives of such terms or other variations on such terms or comparable terminology. These statements are just predictions and are subject to risks and uncertainties that could cause the actual events or results to differ materially. These risks and uncertainties include, among others: market and other conditions, our ability to successfully commercialize Healight Platform Technology, our ability to obtain FDA approval for the Healight Platform Technology, the effectiveness of the Healight Platform Technology in treating patients with COVID-19 or other illnesses, our ability to adequately protect the intellectual property associated with the Healight Platform Technology, regulatory delays, the reliability of the Healight Platform Technology in killing viruses and bacteria, market acceptance of UV based medical devices, the regulatory and commercial risks associated with introducing the COVID-19 rapid tests, any delays in shipment that may impact our ability to distribute the COVID-19 rapid tests, any reputational harm we may incur if there are delays in receiving the shipment of the COVID-19 rapid tests, our ability to enforce the exclusivity provisions of the distribution agreements, the reliability of serological testing in detecting COVID-19, shipping delays and their impact on our ability to introduce the COVID-19 rapid tests, the ability of the COVID-19 rapid tests to accurately and reliably test for COVID-19, the manufacturers of the COVID-19 rapid tests’ ability to manufacture such testing kits on a high volume scale, manufacturing problems or delays related to the COVID-19 rapid tests, our ability to satisfy any labelling conditions or other FDA or other regulatory conditions to sell the COVID-19 rapid test kits, the demand or lack thereof for the COVID-19 rapid test kits, our ability to obtain additional COVID-19 rapid tests to meet demand, our ability to secure additional tests if the manufacturers of the COVID-19 rapid tests are unable to meet demand, the effects of the business combination of Aytu and the Commercial Portfolio and the recently completed merger ("Merger") with Innovus Pharmaceuticals, including the combined company's future financial condition, results of operations, strategy and plans, the ability of the combined company to realize anticipated synergies in the timeframe expected or at all, changes in capital markets and the ability of the combined company to finance operations in the manner expected, the diversion of management time on Merger-related issues and integration of the Commercial Portfolio, the ultimate timing, outcome and results of integrating the operations the Commercial Portfolio and Innovus with Aytu's existing operations, risks relating to gaining market acceptance of our products, obtaining or maintaining reimbursement by third-party payors for our prescription products, the potential future commercialization.
 
Contact for Media and Investors:
 
James Carbonara
Hayden IR
(646) 755-7412
james@haydenir.com
 
Source: Aytu BioScience, Inc.
 
 
 
 
Aytu BioScience, Inc.
Consolidated Statements of Operations Information
(unaudited)
 
 
 
 Three Months Ended March 31,
 
 
 Nine Months Ended March 31,
 
 
 
2020
 
 
2019
 
 
2020
 
 
2019
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Revenues
 
 
 
 
 
 
 
 
 
 
 
 
 Product revenue, net
 $8,156,173 
 $2,372,016 
 $12,771,235 
 $5,598,836 
 License revenue
   
  5,776 
   
  5,776 
 Total revenue
  8,156,173 
  2,377,792 
  12,771,235 
  5,604,612 
 
    
    
    
    
 Operating expenses
    
    
    
    
     Cost of sales
  1,998,659 
  616,853 
  2,980,425 
  1,552,950 
 Research and development
  78,502 
  108,901 
  223,197 
  413,808 
 Selling, general and administrative
  9,501,469 
  5,368,762 
  21,164,072 
  13,991,516 
 Selling, general and administrative - related party
   
  6,797 
   
  351,843 
 Amortization of intangible assets
  1,370,986 
  575,117 
  2,899,553 
  1,561,137 
 Total operating expenses
  12,949,616 
  6,676,430 
  27,267,247 
  17,871,254 
 
    
    
    
    
 Loss from operations
  (4,793,443)
  (4,298,638)
  (14,496,012)
  (12,266,642)
 
    
    
    
    
 Other (expense) income
    
    
    
    
 Other (expense), net
  (538,862)
  (194,703)
  (1,181,206)
  (398,833)
 Gain from derecognition of contingent consideration
   
   
  5,199,806 
   
 Gain from warrant derivative liability
   
  (2,521)
  1,830 
  65,468 
 Total other (expense) income
  (538,862)
  (197,224)
  4,020,430 
  (333,365)
 
    
    
    
    
 Net loss
 $(5,332,305)
 $(4,495,862)
 $(10,475,582)
 $(12,600,007)
 
    
    
    
    
 Weighted average number of common shares outstanding
  35,275,296 
  9,061,023 
  22,616,962 
  5,785,669 
 
    
    
    
    
 Basic and diluted net loss per common share
 $(0.15)
 $(0.50)
 $(0.46)
 $(2.18)
 
    
    
    
    
 
 
 
 
Aytu BioScience, Inc.
Consolidated Balance Sheet Information
 

 
 March 31,
 
 
 June 30,
 
 
 
2020
 
 
2019
 
 
 
 (Unaudited)
 
 
 
 
 Assets
 Current assets
 
 
 
 
 
 
 Cash and cash equivalents
 $62,264,676 
 $11,044,227 
 Restricted cash
  251,407 
  250,000 
 Accounts receivable, net
  10,203,423 
  1,740,787 
 Inventory, net
  3,854,685 
  1,440,069 
 Prepaid expenses and other
  4,830,881 
  957,781 
 Other current assets
  1,849,598 
   
 Total current assets
  83,254,670 
  15,432,864 
 
    
    
 
    
    
 Fixed assets, net
  288,415 
  203,733 
 Right-of-use asset
  675,980 
   
 Licensed assets, net
  17,155,632 
  18,861,983 
 Patents and tradenames, net
  11,724,626 
  220,611 
 Product technology rights, net
  21,754,166 
   
 Deposits
  38,981 
  2,200 
 Goodwill
  24,061,333 
   
 Total long-term assets
  75,699,133 
  19,288,527 
 Total assets
 $158,953,803 
 $34,721,391 
 
    
    
 Liabilities
 Current liabilities
    
    
 Accounts payable and other
 $6,956,091 
 $2,133,522 
 Accrued liabilities
  9,830,373 
  1,311,488 
 Accrued compensation
  2,210,288 
  849,498 
 Current lease liability
  289,238 
   
 Current contingent consideration
  947,449 
  1,078,068 
 Current portion of fixed payment arrangements
  17,395,219 
   
 Current portion of CVR liabilities
  786,564 
   
 Notes payable, net
  3,617,680 
   
 Total current liabilities
  42,032,902 
  5,372,576 
 
    
    
 Long-term contingent consideration, net of current portion
  17,806,573 
  22,247,796 
 Long-term lease liability, net of current portion
  804,393 
   
 Long-term fixed payment arrangements, net of current portion
  8,162,494 
   
 Long-term CVR liabilities, net of current portion
  4,432,254 
   
 Warrant derivative liability
  11,371 
  13,201 
 Total liabilities
  73,249,987 
  27,633,573 
 
    
    
 Commitments and contingencies
    
    
 
    
    
 Stockholders' equity
    
    
 Preferred Stock, par value $.0001; 50,000,000 shares authorized; shares issued and outstanding 9,805,845 and 3,594,981, respectively as of March 31, 2020 (unaudited) and June 30, 2019.
  981 
  359 
 Common Stock, par value $.0001; 200,000,000 shares authorized; shares issued and outstanding 100,610,380 and 17,538,071, respectively as of March 31, 2020 (unaudited) and June 30, 2019.
  10,061 
  1,754 
 Additional paid-in capital
  202,557,856 
  113,475,205 
 Accumulated deficit
  (116,865,082)
  (106,389,500)
 Total stockholders' equity
  85,703,816 
  7,087,818 
 
    
    
 Total liabilities and stockholders' equity
 $158,953,803 
 $34,721,391 
 
    
    
 
 
 
 
Aytu BioScience, Inc.
Condensed Consolidated Cash Flow Information
(Unaudited)
 
 
   Nine Months Ended March 31,
 
 
2020
 
 
  2019    
 
 
 
 
 
 
 
 
       
 
Operating Activities
 
 
 
 
       
 
 
Net loss
 
 $(10,475,582)
 $(12,600,007)
 
Adjustments to reconcile net loss to cash used in operating activities:
 
    
 
       
 
 
Depreciation, amortization and accretion
 
  3,780,310 
  1,974,213 
 
Stock-based compensation expense
 
  590,826 
  722,842 
 
Derecognition of contingent consideration
 
  (5,199,806)
   
 
Gain on the change in fair value of CVR payout
 
  (267,130)
   
 
Issuance of common stock to employee
 
   
  11,690 
 
Derivative income
 
  (1,830)
  (65,468)
 
Changes in operating assets and liabilities:
 
    
 
       
 
 
(Increase) in accounts receivable
 
  (8,183,810)
  (797,576)
 
(Increase) in inventory
 
  (345,452)
  (191,110)
 
(Increase) in prepaid expenses and other
 
  (1,611,681)
  (364,831)
 
(Increase) in other current assets
 
  (358,022)
   
 
(Decrease) in accounts payable and other
 
  (4,912,245)
  (191,331)
 
Increase in accrued liabilities
 
  6,761,319 
  758,370 
 
Increase in accrued compensation
 
  271,560 
  250,912 
 
(Decrease) in fixed payment arrangements
 
  (657,655)
   
 
Increase in interest payable
 
   
  134,795 
 
Net cash used in operating activities
 
  (20,609,198)
  (10,357,501)
 
 
 
    
 
       
 
 
Investing Activities
 
    
 
       
 
 
Deposit
 
   
  2,888 
 
Purchases of fixed assets
 
   
  (59,848)
 
Contingent consideration payment
 
  (151,648)
  (408,917)
 
Cash received from acquisition
 
  390,916 
   
 
Purchase of assets
 
  (5,850,000)
  (500,000)
 
Net cash used in investing activities
 
  (5,610,732)
  (965,877)
 
 
 
    
 
       
 
 
Financing Activities
 
    
 
       
 
 
Issuance of preferred, common stock and warrants
 
  58,999,666 
  15,180,000 
 
Issuance costs related to preferred, common stock and warrants
 
  (5,280,426)
  (1,479,963)
 
Warrant exercises
 
  22,989,666 
  258,512 
 
Preferred stock converted in common stock
 
  92,880 
   
 
Issuance of note payable
 
  640,000 
  5,000,000 
 
Net cash provided by financing activities
 
  77,441,786 
  18,958,549 
 
 
 
    
 
       
 
 
Net change in cash, restricted cash and cash equivalents
 
  51,221,856 
  7,635,171 
 
Cash, restricted cash and cash equivalents at beginning of period
 
  11,294,227 
  7,112,527 
 
Cash, restricted cash and cash equivalents at end of period
 
 $62,516,083 
 $14,747,698 
 
     
 
Supplemental disclosures of cash and non-cash investing and financing transactions  
Cash paid for interest
 $392,641 
 $ 
Fair value of right-to-use asset and related lease liability
  354,929 
   
Issuance of Series G preferred stock due to acquisition of the Cerecor portfolio of pediatrics therapeutics
  5,559,914 
   
Issuance of Series H preferred stock due to acquisition of the Innovus
  12,805,263 
   
Inventory payment included in accounts payable
  460,416 
   
Contingent consideration included in accounts payable
  27,571 
  29,348 
Fixed payment arrangements included in accounts payable
  501,766 
   
Exchange of convertible preferred stock into common stock
  1,559 
   
Return deductions received by Cerecor
  2,000,000 
   
Issuance of restricted stock
  107 
   
Cashless warrant exercises
  792 
   
Fair value of warrants issued to investors and underwriters
   
  1,888,652 
Issuance of preferred stock related to purchase of asset
   
  519,600 
Contingent consideration related to purchase of asset
 $ 
 $8,833,219 
 
 

The following information was filed by Aytu Bioscience, Inc (AYTU) on Thursday, May 14, 2020 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-K Annual Report statement of earnings and operation as management may choose to highlight particular information in the press release.

View differences made from one year to another to evaluate Aytu Bioscience, Inc's financial trajectory

Compare SEC Filings Year-over-Year (YoY) and Quarter-over-Quarter (QoQ)
Sample 10-K Year-over-Year (YoY) Comparison

Compare this 10-K Annual Report to its predecessor by reading our highlights to see what text and tables were  removed  ,   added    and   changed   by Aytu Bioscience, Inc.

Continue

Never Miss A New SEC Filing Again


Real-Time SEC Filing Notifications
Screenshot taken from Gmail for a new 10-K Annual Report
Last10K.com Member Feature

Receive an e-mail as soon as a company files an Annual Report, Quarterly Report or has new 8-K corporate news.

Continue

We Highlighted This SEC Filing For You


SEC Filing Sentiment Analysis - Bullish, Bearish, Neutral
Screenshot taken from Wynn's 2018 10-K Annual Report
Last10K.com Member Feature

Read positive and negative remarks made by management in their entirety without having to find them in a 10-K/Q.

Continue

Widen Your SEC Filing Reading Experience


Increased Reading Area for SEC Filings
Screenshot taken from Adobe Inc.'s 10-Q Quarterly Report
Last10K.com Member Feature

Remove data columns and navigations in order to see much more filing content and tables in one view

Continue

Uncover Actionable Information Inside SEC Filings


SEC Filing Disclosures
Screenshot taken from Lumber Liquidators 10-K Annual Report
Last10K.com Member Feature

Read both hidden opportunities and early signs of potential problems without having to find them in a 10-K/Q

Continue

Adobe PDF, Microsoft Word and Excel Downloads


Download Annual and Quarterly Reports as PDF, Word and Excel Documents
Screenshots of actual 10-K and 10-Q SEC Filings in PDF, Word and Excel formats
Last10K.com Member Feature

Export Annual and Quarterly Reports to Adobe PDF, Microsoft Word and Excel for offline viewing, annotations and analysis

Continue

FREE Financial Statements


Download Annual and Quarterly Reports as PDF, Word and Excel Documents
Screenshot of actual balance sheet from company 10-K Annual Report
Last10K.com Member Feature

Get one-click access to balance sheets, income, operations and cash flow statements without having to find them in Annual and Quarterly Reports

Continue for FREE

Intrinsic Value Calculator


Intrinsic Value Calculator
Screenshot of intrinsic value for AT&T (2019)
Last10K.com Member Feature

Our Intrinsic Value calculator estimates what an entire company is worth using up to 10 years of financial ratios to determine if a stock is overvalued or not

Continue

Financial Stability Report


Financial Stability Report
Screenshot of financial stability report for Coco-Cola (2019)
Last10K.com Member Feature

Our Financial Stability reports uses up to 10 years of financial ratios to determine the health of a company's EPS, Dividends, Book Value, Return on Equity, Current Ratio and Debt-to-Equity

Continue

Get a Better Picture of a Company's Performance


Financial Ratios
Available Financial Ratios
Last10K.com Member Feature

See how over 70 Growth, Profitability and Financial Ratios perform over 10 Years

Continue

Log in with your credentials

or    

Forgot your details?

Create Account